Health and Wellness Coaching to Improve Adherence to Healthy Habits and Treatment Plans in Papillary and Follicular Thyroid Cancer Survivors

NCT07545837 | Not Yet Recruiting

• 2 other identifiers: 25-011068BeWell360
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates the impact of a patient-centered health and wellness coaching (HWC) intervention on adherence to treatment plans and healthy lifestyle practices in patients with papillary or follicular thyroid cancer. Treatment for thyroid cancer often involves surgery, radioactive iodine and/or lifelong levothyroxine with regular monitoring of thyroid stimulating hormone levels. Despite strong survival rates, patients frequently report fatigue, cognitive issues, mood changes, and disruptions in daily life. Treatment burden and psychosocial strain often impair the ability to follow the treatment plan and healthy lifestyle. Studies have shown that HWC motivates patients to take ownership and accountability to perform positive and healthy behavioral changes. HWC may have a positive impact on health-related goal-setting processes and improve self-care and healthcare outcomes in certain settings. It is not yet known how HWC impacts thyroid cancer patients. Incorporating HWC into survivorship care may improve adherence to treatment plans and healthy lifestyle practices in patients with papillary or follicular thyroid cancer.

Conditions

Thyroid Gland Follicular Carcinoma; Thyroid Gland Papillary Carcinoma

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Assessed by the number enrolled out of the number of eligible participants approached

  Up to 1 year

• Retention rate

  Assessed by the number of participants who complete follow-up sessions

  At 6 months

• Session completion rates

  Assessed by the number of sessions attended (out of 6). Success is defined as attendance at ≥ 4 of 6 sessions attended.

  Up to 6 months

• Study completion rate

  Assessed by the number of participants who complete study compared to the number of participants lost to-follow-up.

  At baseline and at 6 months

• Intervention fidelity

  Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements

  Up to 6 months

Secondary Outcomes (3)

• Rate of adherence to medication schedule

  Up to 6 months

• Self-reported rate of adherence to lifestyle care plan

  Up to 6 months

• Change in LMWPHI score

  At baseline and at 6 months

Study Arms (1)

Supportive care (HWC)

EXPERIMENTAL

Patients attend an initial HWC session over 60 minutes and then attend follow-up HWC sessions over 20-60 minutes each monthly for up to 5 months.

Other: Counseling; Other: Interview; Other: Questionnaire Administration

Interventions

Counseling OTHER

Attend HWC sessions

Also known as: Counseling Intervention

Supportive care (HWC)

Interview OTHER

Ancillary studies

Supportive care (HWC)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (HWC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years
• Histologically confirmed papillary or follicular thyroid carcinoma
• Status post total thyroidectomy ± radioactive iodine therapy
• Receiving levothyroxine monotherapy (no triiodothyronine \[T3\] or desiccated thyroid products)
• Thyroid-stimulating hormone (TSH) \< 4 uIU/mL at ≥ 3 months post-thyroidectomy
• English proficiency
• Ability to provide informed consent

You may not qualify if:

• Medullary or anaplastic thyroid carcinoma
• Current systemic therapy for thyroid or other cancers
• Cognitive or psychiatric impairment precluding participation
• Inability to complete study procedures

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Adenocarcinoma, Follicular; Thyroid Cancer, Papillary

Interventions

Counseling; Interviews as Topic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma, Papillary; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Abd Moain Abu Dabrh, MB, BCh, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Megan Warner

CONTACT

904-953-0476

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)